why inject diluted standard solution in related substance
analysis by HPLC?
- 3 Answers
- 16041 Views
- Biocon, Sun Pharma, I also Faced
- E-Mail Answers
Answer Posted / sunil
Actually it is based on the impurity level if any impurity does not meet his LOQ level at that concentration w.r.t the API in that case we need to increase concentration of the API and if the peak is normal no need to prepare diluted std but if peak goes saturation in that case need to inject diluted std at SHI level
| Is This Answer Correct ? | 1 Yes | 0 No |
Post New Answer View All Answers
in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?
how you start RS method development when for new product?
identification is for unknown? qualification for known? reporting for LOQ?
what is mean by peak intigrity?
2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.
How can the GC or HPLC method is selected to determine the impurity profile in drug product?
For standardization of volumetric solutions, acceptance limit for concentration is considered as 10% of nominal concentration and %RSD as NMT 0.2% (for appropriate no. of replicates). But , if %RSD has not met, what should be further action?
How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?
what is mean by nitrosamine impurities?
A ha tc is actual defination of retention time?
Which type of column should i use to check the purity of high molecular weight protein using HPLC reverse phase column chromatography? Hi everyone. I wanna to check the purity of high molecular weight protein (collagen) with MW of ~130 kDa using a HPLC. I know C18
how to develop the icp ms method? Application of icp ms?
How can I develope method of dissolution by HPLC OR UV
what type of question will ask in the interview of lab chemist.
why are measure gas flow " ml " in Gas chromatography
